CLDN18.2 Targeting PET Imaging in Patients With Gastrointestinal Tumors

NCT ID: NCT04883970

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-13

Study Completion Date

2024-05-31

Brief Summary

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The objective of the study is to constrcut a noninvasive approach 124I-18B10(10L) PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from CLDN18.2 targeting treatment.

Detailed Description

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Conditions

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Gastrointestinal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Imaging cohort

All study participants will be allocated to this arm (single-arm study). Study participants will undergo 124I-18B10(10L) PET/CT scans

Group Type EXPERIMENTAL

124I-18B10(10L) PET/CT

Intervention Type OTHER

Study participants will undergo 124I-18B10(10L) PET/CT scans

Interventions

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124I-18B10(10L) PET/CT

Study participants will undergo 124I-18B10(10L) PET/CT scans

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1\. Aged \>18 years old; ECOG 0 or 1;
* 2\. Patients with Gastrointestinal tumors;
* 3\. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
* 4\. life expectancy \>=12 weeks.

Exclusion Criteria

* 1\. Significant hepatic or renal dysfunction;
* 2\. Is pregnant or ready to pregnant;
* 3\. Cannot keep their states for half an hour;
* 4\. Refusal to join the clinical study;
* 5\. Suffering from claustrophobia or other mental diseases;
* 6\. Any other situation that researchers think it is not suitable to participate in the experiment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Hua Zhu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hua Zhu

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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HUA ZHU

Beijing, , China

Site Status

Countries

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China

References

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Wang S, Qi C, Ding J, Li D, Zhang M, Ji C, Jiang F, Teng F, Yu J, Qian X, Wang F, Shen L, Gao J, Yang Z, Zhang C, Zhu H. First-in-human CLDN18.2 functional diagnostic pet imaging of digestive system neoplasms enables whole-body target mapping and lesion detection. Eur J Nucl Med Mol Imaging. 2023 Jul;50(9):2802-2817. doi: 10.1007/s00259-023-06234-z. Epub 2023 Apr 26.

Reference Type DERIVED
PMID: 37099132 (View on PubMed)

Other Identifiers

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2021KT57

Identifier Type: -

Identifier Source: org_study_id

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